Impact of the SARS-CoV-2 pandemic on clinical trials in the ECFS-CTN during 2020

Silke van Koningsbruggen-Rietschel; Fiona Dunlevy; Veerle Bulteel; Kate Hayes; Anne Verbrugge; Damian Downey

Abstract

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has disrupted clinical trials. The European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) tracked disruption to CF trials via regular surveys to adult and pediatric clinics of member sites throughout 2020. We published results to May 2020 (doi: 10.1183/13993003.02114-2020) and now report updated data to the end of 2020.
Ongoing trials were heavily impacted up to May. Trial participant visits, new enrolment and monitoring visits were widely banned, with frequent home delivery of study drug (Table 1). From June to December, trial visits, new enrolment and onsite monitoring were mostly allowed, and home delivery of study drug dropped accordingly. The set-up of new trials was heavily impacted in March but recovered substantially from June on. Some sites had reduced staff available to work on CF trials. Table 2 presents how remote visits and measures were used by sites from June to December.
Much of the early trial disruption resolved by end 2020, however challenges remain to protect the progress of clinical research in CF during the pandemic.

Original language	English
Publication status	Published - 11 Jun 2021
Event	ECFS 2021 - Digital Duration: 09 Jun 2021 → 12 Jun 2021 https://www.ecfs.eu/digital2021

Conference

Conference	ECFS 2021
Period	09/06/2021 → 12/06/2021
Internet address	https://www.ecfs.eu/digital2021

Keywords

COVID-19; opportunity to learn; mathematics education; disadvantage; low attainers; secondary schools

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

https://www.ecfs.eu/digital2021Licence: Unspecified

1 Article

Protecting Clinical Trials in Cystic Fibrosis; COVID-19 Mitigation Measures Crowd Sourced from the European Cystic Fibrosis Society Clinical Trials Network
van Koningsbruggen-Rietschel, S., Dunlevy, F., Bulteel, V., Hayes, K., Verbrugge, A., Janssens, H., Dufeu, N., Simmonds, N. J., Dupont, L. J. & Downey, D. G., 28 Aug 2021, (Early online date) In: Trials. p. 1 11 p.
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Cite this

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title = "Impact of the SARS-CoV-2 pandemic on clinical trials in the ECFS-CTN during 2020",

abstract = "Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has disrupted clinical trials. The European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) tracked disruption to CF trials via regular surveys to adult and pediatric clinics of member sites throughout 2020. We published results to May 2020 (doi: 10.1183/13993003.02114-2020) and now report updated data to the end of 2020. Ongoing trials were heavily impacted up to May. Trial participant visits, new enrolment and monitoring visits were widely banned, with frequent home delivery of study drug (Table 1). From June to December, trial visits, new enrolment and onsite monitoring were mostly allowed, and home delivery of study drug dropped accordingly. The set-up of new trials was heavily impacted in March but recovered substantially from June on. Some sites had reduced staff available to work on CF trials. Table 2 presents how remote visits and measures were used by sites from June to December.Much of the early trial disruption resolved by end 2020, however challenges remain to protect the progress of clinical research in CF during the pandemic.",

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author = "{van Koningsbruggen-Rietschel}, Silke and Fiona Dunlevy and Veerle Bulteel and Kate Hayes and Anne Verbrugge and Damian Downey",

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T1 - Impact of the SARS-CoV-2 pandemic on clinical trials in the ECFS-CTN during 2020

AU - van Koningsbruggen-Rietschel, Silke

AU - Dunlevy, Fiona

AU - Bulteel, Veerle

AU - Hayes, Kate

AU - Verbrugge, Anne

AU - Downey, Damian

PY - 2021/6/11

Y1 - 2021/6/11

N2 - Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has disrupted clinical trials. The European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) tracked disruption to CF trials via regular surveys to adult and pediatric clinics of member sites throughout 2020. We published results to May 2020 (doi: 10.1183/13993003.02114-2020) and now report updated data to the end of 2020. Ongoing trials were heavily impacted up to May. Trial participant visits, new enrolment and monitoring visits were widely banned, with frequent home delivery of study drug (Table 1). From June to December, trial visits, new enrolment and onsite monitoring were mostly allowed, and home delivery of study drug dropped accordingly. The set-up of new trials was heavily impacted in March but recovered substantially from June on. Some sites had reduced staff available to work on CF trials. Table 2 presents how remote visits and measures were used by sites from June to December.Much of the early trial disruption resolved by end 2020, however challenges remain to protect the progress of clinical research in CF during the pandemic.

AB - Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has disrupted clinical trials. The European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) tracked disruption to CF trials via regular surveys to adult and pediatric clinics of member sites throughout 2020. We published results to May 2020 (doi: 10.1183/13993003.02114-2020) and now report updated data to the end of 2020. Ongoing trials were heavily impacted up to May. Trial participant visits, new enrolment and monitoring visits were widely banned, with frequent home delivery of study drug (Table 1). From June to December, trial visits, new enrolment and onsite monitoring were mostly allowed, and home delivery of study drug dropped accordingly. The set-up of new trials was heavily impacted in March but recovered substantially from June on. Some sites had reduced staff available to work on CF trials. Table 2 presents how remote visits and measures were used by sites from June to December.Much of the early trial disruption resolved by end 2020, however challenges remain to protect the progress of clinical research in CF during the pandemic.

KW - COVID-19; opportunity to learn; mathematics education; disadvantage; low attainers; secondary schools

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Y2 - 9 June 2021 through 12 June 2021

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